Trial Outcomes & Findings for Effects of Acute Intermittent Hypoxia on Sensory Function in Healthy Adults (NCT NCT03283072)

NCT ID: NCT03283072

Last Updated: 2023-08-21

Results Overview

Thermal thresholds. Average reported.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 22 participants
• Primary outcome timeframe: Every 10 minutes for 60 minutes post intervention, average reported
• Results posted on: 2023-08-21

Participant Flow

Participant milestones

Measure	Sequence 1 1. 15 bouts of 2mins:1min hypoxia:hyperoxia 2. 15 bouts of 1mins:1min hypoxia:hyperoxia 3. 8 bouts of 2mins:1min hypoxia:hyperoxia 4. 15 bouts of 1min:1min normoxia	Sequence 2 2\. 15 bouts of 1mins:1min hypoxia:hyperoxia 3. 8 bouts of 2mins:1min hypoxia:hyperoxia 4. 15 bouts of 1min:1min normoxia 1\. 15 bouts of 2mins:1min hypoxia:hyperoxia	Sequence 3 3\. 8 bouts of 2mins:1min hypoxia:hyperoxia 4. 15 bouts of 1min:1min normoxia 1. 15 bouts of 2mins:1min hypoxia:hyperoxia 2. 15 bouts of 1mins:1min hypoxia:hyperoxia	Sequence 4 4\. 15 bouts of 1min:1min normoxia 1. 15 bouts of 2mins:1min hypoxia:hyperoxia 2. 15 bouts of 1mins:1min hypoxia:hyperoxia 3. 8 bouts of 2mins:1min hypoxia:hyperoxia
Overall Study STARTED	7	5	5	5
Overall Study COMPLETED	5	5	5	5
Overall Study NOT COMPLETED	2	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Acute Intermittent Hypoxia on Sensory Function in Healthy Adults

Baseline characteristics by cohort

Measure	Sequence 1 n=5 Participants 15 bouts of 2mins:1min hypoxia:hyperoxia 15 bouts of 1mins:1min hypoxia:hyperoxia 8 bouts of 2mins:1min hypoxia:hyperoxia 15 bouts of 1min:1min normoxia	Sequence 2 n=5 Participants 15 bouts of 1mins:1min hypoxia:hyperoxia 8 bouts of 2mins:1min hypoxia:hyperoxia 15 bouts of 1min:1min normoxia 15 bouts of 2mins:1min hypoxia:hyperoxia	Sequence 3 n=5 Participants 8 bouts of 2mins:1min hypoxia:hyperoxia 15 bouts of 1min:1min normoxia 15 bouts of 2mins:1min hypoxia:hyperoxia 15 bouts of 1mins:1min hypoxia:hyperoxia	Sequence 4 n=5 Participants 15 bouts of 1min:1min normoxia 15 bouts of 2mins:1min hypoxia:hyperoxia 15 bouts of 1mins:1min hypoxia:hyperoxia 8 bouts of 2mins:1min hypoxia:hyperoxia	Total n=20 Participants Total of all reporting groups
Age, Continuous	26.4 years STANDARD_DEVIATION 6.3 • n=5 Participants	19.2 years STANDARD_DEVIATION 1.1 • n=7 Participants	20.8 years STANDARD_DEVIATION 2.0 • n=5 Participants	20.8 years STANDARD_DEVIATION 2.1 • n=4 Participants	22.0 years STANDARD_DEVIATION 5.1 • n=21 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	10 Participants n=21 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	10 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	9 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	9 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=7 Participants	5 participants n=5 Participants	5 participants n=4 Participants	20 participants n=21 Participants

PRIMARY outcome

Timeframe: Every 10 minutes for 60 minutes post intervention, average reported

Population: A 2-way analysis of co-variance with repeated measures (time\*intervention) was conducted with gender as the covariate.

Thermal thresholds. Average reported.

Outcome measures

Measure	Intervention 1 n=20 Participants 1\) 15 bouts of 1 minute hypoxia:1 minute hyperoxia;	Intervention 2 n=20 Participants 2\) 15 bouts of hypoxia for 2 minutes, normoxia to hyperoxia 1 minute;	Intervention 3 n=20 Participants 3\) 8 bouts of hypoxia for 2 minutes, normoxia to hyperoxia 1 minute;	Intervention 4 (Sham) n=20 Participants 4\) normoxia
Sensory Function	46.7 Degrees celsius Standard Deviation 1.5	46.4 Degrees celsius Standard Deviation 1.9	46.1 Degrees celsius Standard Deviation 1.9	45.9 Degrees celsius Standard Deviation 2.1

PRIMARY outcome

Timeframe: Every 10 minutes for 60 minutes post intervention, average reported

Population: 2-way repeated measures ANOVA with gender as the covariate

Temporal summation represents increases in ratings of pain intensity measured using a numeric pain rating scale (0-no pain to 100-worst pain imaginable) to repeated heat stimuli of the same intensity; that is, "summation" represents increases in participant ratings of pain despite the maintenance of a standard temperature and is calculated as the difference between pain rating 1 and pain rating 6. Positive difference scores indicate that pain reported increased over the 6 pulses of heat. Here, the average difference across participants and over time is reported.

Outcome measures

Measure	Intervention 1 n=20 Participants 1\) 15 bouts of 1 minute hypoxia:1 minute hyperoxia;	Intervention 2 n=20 Participants 2\) 15 bouts of hypoxia for 2 minutes, normoxia to hyperoxia 1 minute;	Intervention 3 n=20 Participants 3\) 8 bouts of hypoxia for 2 minutes, normoxia to hyperoxia 1 minute;	Intervention 4 (Sham) n=20 Participants 4\) normoxia
Temporal Sensory Summation	17.4 score on a scale Standard Deviation 13.3	11.7 score on a scale Standard Deviation 10.2	10.9 score on a scale Standard Deviation 11.2	11.9 score on a scale Standard Deviation 15.6

PRIMARY outcome

Timeframe: Every 10 minutes for 60 minutes post intervention, average reported

Population: A 2-way analysis of co-variance with repeated measures (time\*intervention) was conducted with gender as the covariate.

Pressure threshold is the force at which the sensation of pressure first is considered painful by the participant, average reported

Outcome measures

Measure	Intervention 1 n=20 Participants 1\) 15 bouts of 1 minute hypoxia:1 minute hyperoxia;	Intervention 2 n=20 Participants 2\) 15 bouts of hypoxia for 2 minutes, normoxia to hyperoxia 1 minute;	Intervention 3 n=20 Participants 3\) 8 bouts of hypoxia for 2 minutes, normoxia to hyperoxia 1 minute;	Intervention 4 (Sham) n=20 Participants 4\) normoxia
Sensory Function - Pressure	4.4 kilograms force Standard Deviation 3.4	4.6 kilograms force Standard Deviation 2.5	4.3 kilograms force Standard Deviation 2.8	4.3 kilograms force Standard Deviation 3.1

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mark Bishop

University of Florida

Phone: 3522736112

Email: bish@ufl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place